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Associate Director, Medical Writing
Rhythm PharmaceuticalsUnited Statesfull_timeVerifiedPosted 5 May 2025
About the role
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases. Working at Rhythm means that you are part of a passionate team dedicated to advancing precision medicines that address the root cause of these rare diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently develop as well as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the Head of Medical Writing yet works autonomously to lead work with cross-functional stakeholders to advance Rhythm’s goal of delivering precision medicines to patients living with rare, neuroendocrine diseases.
Responsibilities and Duties
Qualifications and Skills
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases. Working at Rhythm means that you are part of a passionate team dedicated to advancing precision medicines that address the root cause of these rare diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently develop as well as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the Head of Medical Writing yet works autonomously to lead work with cross-functional stakeholders to advance Rhythm’s goal of delivering precision medicines to patients living with rare, neuroendocrine diseases.
Responsibilities and Duties
- Author and serve as lead writer for complex clinical and regulatory documents (e.g., protocols and amendments, clinical study reports, Investigator’s Brochures, regulatory submissions and responses to health authority inquiries) and contribute to the clinical study design and regulatory/clinical strategies
- Drive and/or oversee document execution, such as: define document development steps, implement review and revision processes, develop timelines, assign resources, facilitate document-related meetings, provide cross-functional updates and define data needs, etc. to ensure timely completion of key documents for complex global programs
- Serve as the Medical Writing Lead on cross-functional core program teams
- Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents (e.g., Regulatory submissions, Annual Reports and updates, DSURs, PBRERs, Posters and Manuscripts)
- Provide hands-on support for the global clinical trial transparency requirements from study registrations to results postings (e.g., clinicaltrials.gov, EudraCT, CTIS)
- Proactively contribute to development and implementation of Medical Writing best practices, policies, SOPs and process improvement initiatives leading to efficient and improved standards and systems for authoring, review, editing and finalization of documents
- Develop and refine templates to improve inter-department/program alignment and efficiency in accordance with standards and regulatory guidelines and requirements
- Define document development strategy and resource needs for programs, including medical writing vendor engagement and oversight
- Oversee or act as lead Medical Writer, and serve as key communicator and liaison between any vendors or service providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory
- In collaboration with Procurement, responsibilities may include initiating projects using external vendors from bid stage through project completion
- Contribute to and/or lead continuous development of the Medical Writing function
Qualifications and Skills
- Bachelor’
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